56 Participants Needed

Urine Tumor DNA Testing for Bladder Cancer

LT
CO
Overseen ByColette Osborne
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lahey Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for detecting non-muscle invasive bladder cancer using urine tumor DNA, potentially reducing the need for cystoscopy procedures (a camera-based examination inside the bladder). Researchers are studying the UroAmp Test (a urine DNA test) to determine if it can be as effective as regular check-ups. Participants are divided into two groups: one receives regular follow-ups, while the other undergoes fewer cystoscopies. Suitable candidates have high-risk bladder cancer, have undergone treatments like BCG or gemcitabine/docetaxel, and have a clear initial post-treatment check-up. As an unphased trial, this study offers patients the chance to contribute to innovative research that could simplify future bladder cancer monitoring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the UroAmp Test is safe for use in bladder cancer surveillance?

Studies have shown that the UroAmp test is safe. In research involving 66 patients and 933 test instances, no serious side effects occurred. Only mild side effects appeared, indicating that the test is generally well-tolerated. No reports of severe reactions emerged, which reassures those considering joining a trial using this test.12345

Why are researchers excited about this trial?

Researchers are excited about the UroAmp Test for bladder cancer because it offers a non-invasive way to detect tumor DNA through urine samples. Traditional methods often rely on frequent cystoscopy, which is more invasive and uncomfortable for patients. The UroAmp Test aims to simplify monitoring by identifying cancerous cells without the need for invasive procedures, potentially leading to earlier detection and less frequent medical visits. This approach could significantly improve patient comfort and compliance while maintaining effective surveillance for bladder cancer.

What evidence suggests that the UroAmp Test is effective for detecting non-muscle invasive bladder cancer?

Research has shown that the UroAmp test is promising for detecting bladder cancer. Studies have found that UroAmp can identify cancer that other methods, such as a bladder exam with a camera (cystoscopy) or a urine test for cancer cells (urine cytology), might miss. One study revealed that patients who tested positive with UroAmp were more likely to experience cancer recurrence compared to those who tested negative. This suggests that UroAmp can help identify patients at higher risk of cancer returning. In this trial, participants in the De-Intensified Arm will undergo less-frequent cystoscopy surveillance, potentially guided by UroAmp results. Overall, UroAmp could be a valuable tool in tailoring bladder cancer treatment by identifying those who might need closer monitoring.16789

Who Is on the Research Team?

MB

Matthew B Clements, MD, MS

Principal Investigator

Lahey Hospital & Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with non-muscle invasive bladder cancer. It's designed to see if a urine test can help reduce the number of times they need cystoscopy, which is a procedure that looks inside the bladder.

Inclusion Criteria

My bladder cancer is considered high-risk.
I have received BCG or gemcitabine/docetaxel treatment.
My initial tests after starting treatment show no cancer signs.

Exclusion Criteria

My bladder cancer is high-risk and was diagnosed within the last 3 years.
I have had bladder treatments with medication placed directly into the bladder.
My cancer has a specific genetic variation.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either standard surveillance or de-intensified surveillance based on urine tumor DNA (utDNA) testing

24 months
Regular follow-ups as per assigned arm

Interim Analysis

Evaluation of conversion rate from low-risk to high-risk on the utDNA test after 50% enrollment

3 months

Follow-up

Participants are monitored for event-free survival, recurrence-free survival, and patient-reported outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • UroAmp Test
Trial Overview The UroAmp Test by Convergent Genomics is being tested to determine its effectiveness in using urine tumor DNA as an indicator for adjusting surveillance frequency in patients with non-muscle invasive bladder cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: De-Intensified ArmExperimental Treatment1 Intervention
Group II: Standard Surveillance ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lahey Clinic

Lead Sponsor

Trials
74
Recruited
245,000+

Citations

Urinary comprehensive genomic profiling predicts ...This study used genomic profiling to detect mutations associated with urothelial carcinoma in patient urine samples collected before and after intravesical ...
Urine Tumor DNA to Stratify the Risk of Recurrence in ...The 18-mo event-free survival (EFS) was significantly lower for UroAmp-positive patients at baseline (23%) than for UroAmp-negative patients (51 ...
NEW STUDY SHOWS UROAMP CAN DETECT BLADDER ...Most striking among the findings was UroAmp's ability to detect minimal residual disease in surveillance patients after cystoscopy and urine ...
New urine-based tumor DNA test may help personalize ...Researchers revealed that testing urine-based tumor DNA (utDNA) can help predict which bladder cancer patients are at higher risk for recurrence after ...
Clinical Cancer Research - AACR JournalsUroAmp is a Clinical Laboratory Improvement Amendments–certified urine test developed to aid in the diagnosis of bladder cancer, predict risk of disease ...
American Urological Association (AUA) 2025 Non-Invasive ...The therapy showed a favorable safety profile across 933 instillations in 66 patients, with no drug-related serious adverse events and only mild (Grade 1-2) ...
Current look at the most promising proteomic and glycomic ...The UroAmp test was effective in predicting 66% of future BCs in urine samples collected 12 years ago, at least 6 years before clinical ...
Clinical Trials in Progress: Bladder CancerThe primary outcome measure is all-cause Event Free Survival (EFS). Secondary endpoints include Recurrence-Free Survival, Progression-Free ...
BOND/CORE-001: uGDB as a Biomarker for Viral Therapy ...The UroAmp assay, a convergent genomic and genetic liquid biopsy, quantifies mutations and DNA alterations in urine tumor DNA to determine ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security